Last Year’s Agenda
Agenda Subject to Change
All Times Listed in Eastern Time
Wednesday, October 16, 2024
11:00–11:10 AM
Welcome and Course Overview
Lauren-Caroline Tadros Potter, Assistant Director, Educational Programs, FDLI
Dominick Paul DiSabatino, Attorney, Sheppard Mullin Richter and Hampton LLP, Curriculum Advisor
11:10 AM–12:00 PM
FDA Regulatory Authority
David L. Rosen, Partner, Foley & Lardner LLP
- FDA Promotional Oversight Authority through the Federal Food, Drug, and Cosmetic Act
- Defining FDA Branches and Divisions Regulating Product Promotion and Types of Advertising
- FDA Guidances Concerning Advertising and Promotion
- FDA Outreach Programs
12:10–1:00 PM
Core Fundamentals
Dominick Paul DiSabatino, Attorney, Sheppard Mullin Richter & Hampton LLP, FDLI Curriculum Advisor
- Key Definitions for Legal, Regulatory, and Marketing Professionals
- Claim Types and the Five Elements of Drug Promotion
- Intent and Why It Matters
- Preparing Submissions
2:00–3:00 PM
Beyond FDA
August Horvath, Partner, Foley Hoag LLP
- Understanding the Role of Other Agencies and Non-Governmental Organizations
- DOJ
- FTC
- SEC
- HHS OIG
- National Advertising Division
- Better Business Bureau
- Fundamental Laws and Guidance Documents in Connection with Other Agencies and Non-Governmental Organizations
- Lanham Act
- False Claims Act
- Anti-Kickback Statute
- Qui Tam Actions
- SEC Anti-Fraud Provisions
- Enforcement
3:10–4:00 PM
Multi-Channel, Pre-Approval, and Non-Promotional Communication
Gillian M. Russell, Counsel, King & Spalding LLP
- Types of Communication
- Defining and Distinguishing Promotional Content from Scientific Exchange
- Accepted Pre-approval Promotion—Coming Soon, Institutional
- Help-Seeking Advertisements—Disease Awareness
- First Amendment
- Digital Advertising and New Technologies
- Social Media Advertising
- Data Privacy
4:10–5:00 PM
Case Study and Practical Implementation
Katherine Armstrong, Deputy Director, National Advertising Division, BBB National Programs
You will have the opportunity to practically apply learnings from this course to a hypothetical case study reviewing promotional materials.